Product Classification

• Device: ventricular bypass (assist) device
• Regulation Description: Ventricular bypass (assist) device.
• Definition: A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.
• Physical State: A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.
• Technical Method: A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.
• Target Area: A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: OKR
• Premarket Review: Circulatory Support, Structural and Vascular Devices (DHT2B); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: PMA
• Regulation Number: 870.3545
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 3-164 ASTM F1830-19
  Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
• 3-165 ASTM F1841-19
  Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• 3-170 ISO 14708-5 Second edition 2020-05
  Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices

Third Party Review

Not Third Party Eligible